Identity
- Trade Name
- BioWax 52/54, 2 kg EUDAMED
- Device Name
- Sredstva za uklapanje EUDAMED
- Model / Reference
- BW52/54-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858888822569 EUDAMED
- Basic UDI-DI
- 385889212HPC30704EMBEP7 EUDAMED
- Direct Marketing DI
- 03858888822569 EUDAMED
- EMDN Code
- W01030704 EMBEDDING MEDIA (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
BioWax 52/54, 2 kg by BioGnost Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 385889212HPC30704EMBEP7 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioGnost Ltd.
- EUDAMED SRN
- HR-MF-000022153
Sources (1)
- EUDAMED 2be582eb-d95c-4a07-a67a-ade583909d8f 61 fields · synced Jul 13, 2026